Good Manufacturing Practice
GMP- EN
- Good Manufacturing Practice
- VI
- Thực hành tốt sản xuất thuốc
- JA
- Good Manufacturing Practice（GMP、医薬品製造の優良基準）
Quality / GxP
Definition
The quality standard for drug manufacturing in Vietnam — currently set by Circular 28/2025/TT-BYT (effective 1 July 2025), which replaced the prior Circular 35/2018/TT-BYT. GMP covers facility, equipment, personnel, materials, manufacturing process, packaging, labelling, quality control, complaints handling, recall and self-inspection. A current GMP certificate is the precondition for issuing a CPP or FSC for export, and for foreign manufacturers to be recognised in the DAV foreign-supplier register.
Sources
- Circular 28/2025/TT-BYT (replaces TT 35/2018/TT-BYT).
- Legal basis: Luật Dược 105/2016 + Luật 44/2024.
See also
- Last reviewed:
- 2026-06-28
- Page updated:
- 2026-06-28